US-based microvascular products maker Micro Medical Solutions (MMS) has obtained CE mark approval for its microvascular device MicroStent, which enables the marketing of the technology in Europe.
MicroStent is a vascular stent developed to minimise below-the-knee amputations for critical limb ischemia (CLI) caused due to peripheral artery disease.
The stent is the centerpiece of an integrated delivery platform and aids amputation prevention in patients with CLI.
Micro Medical Solutions chief executive officer Gregory Sullivan said: "This major milestone for MMS brings our Micro Vascular Integrated Platform, which includes MicroStent, one step closer to becoming available to European physicians.
"We are delighted to share this exciting news with interventionists, who are seeking much-needed innovation in this underserved area."
The micro vascular integrated platform (mVIP) of the firm was commenced to develop technologies for the optimal treatment of CLI lesions below the knee as well as to minimise the risk of amputation.
The mVIP includes MicroBalloon and MicroGuide, in addition to the MicroStent. The MicroBalloon and MicroGuide have also received CE mark and 510(k) clearances.
MMS Regulatory and Clinical Affairs director Greg Mathison said that the firm intends to report data from a US clinical trial of the stent this year.
Micro Medical Solutions focuses on developing products to decrease the rate of amputations, improve clinical outcomes and patient quality of life, as well as reduce the financial and human costs for the treatment of peripheral artery disease and CLI.